A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes on Metformin With or Without Sulfonylurea (SURPASS-AP-Combo)

Lilly

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: Insulin Glargine; Drug: Tirzepatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT04093752

I8F-MC-GPHO (Other Identifier)

17210

Details and patient eligibility

About

The main reason for this study is to compare the study drug tirzepatide to insulin glargine in participants with type 2 diabetes on metformin with or without a sulfonylurea.

Enrollment: 917 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes mellitus
• Treated with stable metformin with or without a sulfonylurea (metformin ≥1000 milligrams/day; sulfonylurea should be at least half the maximum dose) for at least 2 months
• Are insulin-naive (except for the use of insulin for treatment of gestational diabetes or short-term use [≤14 consecutive days] for acute conditions)
• HbA1c ≥7.5% to ≤11.0% at screening
• Stable weight (±5%) ≥3 months, and agree to not initiate a diet and/or exercise program during the study with the intent of reducing body weight other than the lifestyle and dietary measures for diabetes treatment
• Body mass Index (BMI) ≥23 kilograms per meter squared

Exclusion criteria

• Type 1 diabetes mellitus
• Have history of chronic or acute pancreatitis
• Have history of proliferative diabetic retinopathy; or diabetic maculopathy; or non-proliferative diabetic retinopathy that requires acute treatment
• Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months
• Have a history of ketoacidosis or hyperosmolar state/coma
• Have a known clinically significant gastric emptying abnormality, have undergone or plan to have during the course of the study, or chronically take drugs that directly affect GI motility
• Have acute myocardial infarction (MI), stroke or hospitalization due to congestive heart failure (CHF) within 2 months
• Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
• Have been treated with prescription drugs that promote weight loss or similar other body weight loss medications including over the counter (OTC) within 3 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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917 participants in 4 patient groups

5 mg Tirzepatide

Experimental group

Description:

Participants received 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once weekly (QW).

Treatment:

Drug: Tirzepatide

10 mg Tirzepatide

Experimental group

Description:

Participants received 10 mg tirzepatide administered SC QW.

Treatment:

Drug: Tirzepatide

15 mg Tirzepatide

Experimental group

Description:

Participants received 15 mg tirzepatide administered SC QW.

Treatment:

Drug: Tirzepatide

Insulin Glargine

Active Comparator group

Description:

Participants received insulin glargine administered once daily (QD) SC. The starting dose of insulin glargine was 6 Insulin Units (IU)/day at bedtime, titrated to a fasting blood glucose (FBG) between 72-100 milligrams per Deciliter (mg/dL), following a treat-to-target (TTT) algorithm.

Treatment:

Drug: Insulin Glargine